Savara Inc. announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial. A total of 164 patients were randomized. Target enrollment for the trial was 160 patients.

The Company expects to report top line results by the end of second quarter 2024. IMPALA-2 is a global, 48-week, placebo-controlled clinical trial evaluating molgramostim, a novel inhaled biologic, for the treatment of aPAP, a rare lung disease with no approved pharmacological treatments. In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for molgramostim in aPAP based on data from the double-blind treatment period of the Phase 2/3 IMPALA clinical trial.

Initiation of IMPALA-2 was based on results from IMPALA which were published in the New England Journal of Medicine in September 2020. In 2022, the UK'sMedicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation and Innovative Passport Designation to molgramostim for the treatment of aP AP. About the IMPALA-2 Trial IMPALA-2 is an global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg administered once daily by inhalation with matching placebo in patients with aPAP.

The trial is being conducted at approximately 50 clinical trial sites in 18 countries across North America, Europe, Japan, South Korea, and Australia. The primary efficacy variable is change from baseline in% predicted diffusing capacity for carbon monoxide (DLCO), a gas exchange measure. Three secondary efficacy variable evaluate clinical measures of direct patient benefit: St.

George's Respiratory Questionnaire (SGRQ) Total Score, SGRQ Activity Component Score, and exercise capacity using a treadmill test.